[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-non-small-cell-lung-cancer-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-non-small-cell-lung-cancer-nsclc":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100569368","phase-2-an-adjuvant-study-to-evaluate-sms001-paclitaxel-in-non-small-cell-lung-cancer-100569368",false,"NCT06693336","An Adjuvant Study to Evaluate SMS001 (Paclitaxel) in Non-Small Cell Lung Cancer","Phase IIa Trial Evaluating the Safety and Therapeutic Effect of SMS001 as an Adjuvant Therapy to Control Tumor Recurrence in Stage Ib-IIIa (N2) Non-Small Cell Lung Cancer (NSCLC) Patients","Inclusion Criteria:\n\n1. Histopathological confirmed NSCLC\n2. Stage Ib, IIa, IIb or IIIa (N2) for both dose escalation and dose confirmation (NOTE: Staging will be according to the AJCC 8th edition)\n3. Age ≥18 years and suitable for lung cancer surgery\n4. No prior chemotherapy and\u002For thoracic radiation therapy\n5. Normal liver, and renal function at study entry\n6. Laboratory requirements:\n\n   1. WBC \\> 2500\u002Fmm3\n   2. Neutrophil \\>1500\u002Fmm3\n   3. Hemoglobin \\>10 g\u002FdL\n   4. Platelet \\>100,000\u002F mm3\n   5. AST and ALT \\\u003C 2.5 x ULN\n   6. Total bilirubin \\\u003C 1.5 x ULN\n   7. Creatinine \\\u003C 2 mg\u002FdL (equivalent to 176.8 μmol\u002FL)\n   8. Normal PT\u002FINR and PTT\n   9. eGFR \\>60mL\u002Fmin\u002F1.73m²\n7. QT interval corrected for heart rate using Frederica's formula (QTcF): males \\\u003C 450msec and females \\\u003C 470msec\n8. Operating surgeon deems patient is candidate for complete surgical resection of lung cancer and lymphadenectomy or lymph node sampling (Wedge resection, segmentectomy or lobectomy are acceptable)\n9. Stated willingness to comply with all study procedures and availability for the duration of the study\n10. Ability to understand and sign informed consent\n11. Women of childbearing potential (WOCBP) must use highly effective methods of contraception for at least 6 months after wafer insertion. Otherwise, women must be postmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone \\[FSH\\] ≥40 mIU\u002FmL \\[or ≥ 40 IU\u002FL\\] if less than 2 y postmenopausal) or be surgically sterile. Men must use highly effective methods of contraception for at least 3 months after wafer insertion. Examples of highly effective contraception include: parenteral contraceptives, oral contraceptives, patch contraceptives, implantable hormonal contraceptives, intrauterine device or system, surgical sterilization (hysterectomy, bilateral oophorectomy, and\u002For bilateral salpingectomy), tubal ligation\u002Focclusion, vasectomized partner, or sexual abstinence, if this is the subject's current practice. Periodic abstinence, i.e., calendar, symptothermal, or post-ovulation methods are not an acceptable form of contraception for this study.\n\nExclusion Criteria:\n\nIf a subject meets any of the following criteria, he\u002Fshe must be excluded from the study.\n\n1. Evidence of locally advanced T3 or T4 NSCLC or distant metastatic disease.\n2. Patients requiring pneumonectomy or sleeve resection.\n3. Known sensitivity to any of the study agent components.\n4. Patients with a previous malignancy within the last 5 years except non-melanoma skin cancer.\n5. Patients receiving induction (neo-adjuvant) chemotherapy and\u002For radiation prior to surgery.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection. dysfunction of major organ (e.g., liver, kidney etc.), symptomatic congestive heart failure. unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Pregnant or nursing female subjects.\n8. Unwilling or unable to follow protocol requirements.\n9. Any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit schedule.","ALL","18 Years","80 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study evaluates the use of SMS001 in patients with lung cancer. SMS001 is a new form of drug Paclitaxel. Doctors want to decide an appropriate safe dose for SMS001 administration, and to see how well it works in treating lung cancer patients.",[27],"Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)",[29,30],"NSCLC","Carcinoma","RECRUITING","2026-03-04",{"date":34,"type":35},"2026-03-06","ACTUAL",{"date":37,"type":35},"2024-11-18",{"date":39,"type":21},"2026-12-30",{"name":41,"class":42},"ToLymph Inc.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100624361","phase-2-ibi363-pd-1il-2-bias-in-combination-with-chemotherapy-as-neoadjuvant-therapy-in-initially-unresectable-stage-iii-non-small-cell-lung-cancer-100624361","NCT07408635","IBI363 (PD-1\u002FIL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer","IBI363 (PD-1\u002FIL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy to Convert Initially Unresectable Stage III Non-Small Cell Lung Cancer To Resectable Disease: a Phase II, Single-Arm Clinical Trial","INCLUSION CRITERIA\n\n1. The patient shall sign the informed consent.\n2. Age ≥ 18 years.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n4. Histologically or cytologically confirmed Stage III (per AJCC 9th) squamous or non-squamous non-small-cell lung cancer (NSCLC) deemed unresectable by the investigator.\n5. Tumours with mixed NSCLC histology must be categorised as either squamous or non-squamous on the basis of the predominant component. Tumours containing both NSCLC and small-cell lung cancer (SCLC) are excluded.\n6. \"Unresectable\" is defined as following: (1) Multistation or confluent metastasis in ipsilateral mediastinal lymph nodes (2)Contralateral or supraclavicular lymph node metastasis (N3) (3)Invasion of critical organs or major blood vessels (4)Extensive invasion of the chest wall and pleura (5)Special anatomical locations (6）Patient intolerance to lobectomy or pneumonectomy.\n7. At least one measurable lesion per RECIST v1.1.\n8. Adequate organ function meet the following standards (within 14 days before first dose, any blood components or growth factor drugs is not permitted):\n\n   * ANC count ≥ 1.5 × 10⁹\u002FL\n   * Platelet count ≥ 100 × 10⁹\u002FL\n   * Hemoglobin ≥ 90 g\u002FL\n   * Serum Cr ≤ 1.5 times of upper limit of normal (ULN) or calculated creatinine clearance (CLcr) ≥ 50 mL\u002Fmin\n   * Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in Gilbert's syndrome)\n   * AST and ALT ≤ 2.5 × ULN\n   * INR or APPT ≤ 1.5 × ULN\n   * left ventricular ejection fraction (LVEF) ≥ 50 %\n9. Contraception and reproductive status:\n10. Fertile female patients must voluntarily use effective contraception during the study period and for at least 3 months after treatment completion, and urine or serum pregnancy test result within 72 hours prior to enrollment are negative and must not be breastfeeding. Male patients with female partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose of IBI363.\n\nEXCLUSION CRITERIA\n\n1. Non-squamous and squamous NSCLC with EGFR active mutation positive, ALK rearrangement, or any other driver mutation with an approved targeted therapy.\n2. History of other malignant tumors within five years or concurrently present, except adequately treated cervical carcinoma in situ, basal- or squamous-cell skin carcinoma, localized prostate cancer after radical prostatectomy, ductal carcinoma in situ after radical prostatectomy, or other tumor deemed cured by the investigator.\n3. Histologically confirmed the presence of small cell lung cancer component.\n4. Participants who have received any systemic anti-cancer treatment.\n5. Clinically significant cardiovascular or cerebrovascular disease, including:\n\n   1. Myocardial infarction or unstable angina within 6 months before first dose\n   2. Stroke or transient ischaemic attack within 6 months before first dose\n   3. Uncontrolled hypertension (systolic ≥ 160 mmHg and\u002For diastolic ≥ 100 mmHg) despite optimal therapy\n   4. Congestive heart failure (NYHA class III-IV)\n   5. Myocarditis\n6. Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids \\>10 mg\u002F day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy are permitted.\n7. Presence of any active autoimmune disease or history of autoimmune disease.\n8. Idiopathic pulmonary fibrosis, organizing pneumonia, drug pneumonia, or active pneumonia shown on CT during screening period have been or are currently present.\n9. History of allogeneic haematopoietic stem-cell or solid-organ transplantation.\n10. The subject has congenital or acquired immune deficiency (such as HIV infected persons).\n11. Active hepatitis (HBsAg positive and HBV DNA \\>the upper limit of normal value; HCV antibody and HCV RNA positive. Subjects who meet the following criteria may be enrolled: HBV-DNA \\\u003C500 IU\u002FmL measured within 28 days prior to study dosing, have received at least 4 weeks of standard antiviral therapy, and are willing to continue antiviral therapy throughout the study period.)\n12. Participants who are allergic to the test drug or any auxiliary materials.\n13. The vaccine was administered within 30 days before first dose or planned during treatment and up to 90 days after the last dose.\n14. Severe active infection within 2 weeks before first dose.\n15. Other factors that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.",{"count":51,"type":21},43,[24],"This study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.",[55,27],"Unresectable Stage III Non-small Cell Lung Cancer","2026-02-12",{"date":58,"type":35},"2026-02-13",{"date":60,"type":35},"2026-01-07",{"date":62,"type":21},"2030-01-06",{"name":64,"class":65},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",1,"Carcinoma, Non-Small Cell Lung Cancer (NSCLC)"]